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PED/PEA-15 Protein, PCOS, Obesity, Insulin Sensitivity Indexes, Metformin, Oral Contraceptives

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ClinicalTrials.gov Identifier: NCT00948402
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : October 14, 2009
Sponsor:
Information provided by:
Federico II University

Study Description
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Brief Summary:
Insulin-resistance plays an important role in polycystic ovary syndrome (PCOS) physiopathology. The phosphoprotein enriched in the diabetes (PED/PEA-15), a 15 kDa protein related to insulin sensitivity, is over-expressed in type 2 diabetic patients and in PCOS women, independently of obesity. The effectiveness of oral contraceptives pills (OCP) or metformin (MET) in PCOS management is still uncertain. Aim of this pilot clinical study was to compare the effects of OCPs or MET on the expression of PED/PEA-15 in association with insulin sensitivity in obese PCOS women. Outcome measures: PED/PEA-15, BMI, plasma glucose and insulin, 1/HOMA-IR, homeostasis model assessment of insulin resistance; QUICKI, quantitative insulin sensitivity check index; ISI: whole-body insulin sensitivity index. Study design: twenty obese PCOS women (age: 24.7±18 yr; BMI: 30±2.4 kg/m2) were randomized according to insulin sensitivity to receive 30 µg ethinylestradiol plus 30 mg drospirenone 21 day/month or MET 1250 mg three times daily for 6 months. Results: At baseline, age and BMI were not different in the two groups; PED/PEA-15 protein expression was higher in MET than in OCP group (p=0.011), along with higher 1/HOMA-IR (p=0.004), and lower QUICKI and ISI (p=0.003 and p<0.001, respectively). After treatment, independently of body weight, only in MET group PED/PEA-15 decreased (p=0.004), along with insulin and 1/HOMA-IR (p<0.001), and QUICKI and ISI increased (p<0.001). Insulin sensitivity indexes improvement correlated significantly with PED/PEA-15 protein expression, but not with BMI. Conclusions: PED/PEA-15 protein over-expression in obese PCOS women with IR reduced after a six month treatment with MET, while remained unchanged in the OCP group. The reduction was independent of body weight, and correlated with insulin sensitivity indexes. This effect further supported MET as a more effective therapy than OCPs for obese PCOS women with IR, also when fertility is not required.

Condition or disease Intervention/treatment Phase
Polycystic Ovarian Syndrome Insulin Sensitivity Drug: Metformin Drug: oral contraceptive Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Metformin Versus Oral Contraceptives on PED/PEA-15 Protein Expression in Obese Women With Polycystic Ovary Syndrome
Study Start Date : December 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : January 2009

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Arms and Interventions
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Arm Intervention/treatment
Experimental: metformin Drug: Metformin
metformin 1250 mg three times daily
Other Name: Biguanides
Active Comparator: oral contraceptive Drug: oral contraceptive
30 µg ethinylestradiol plus 30 mg drospirenone 21 day/month.
Other Name: estroprogestins


Outcome Measures
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Primary Outcome Measures :
  1. PED/PEA-15 protein expression [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. BMI, plasma glucose, plasma insulin, insulin sensitivity indexes (1/HOMA-IR, homeostasis model assessment of insulin resistance; QUICKI, quantitative insulin sensitivity check index; ISI, whole-body insulin sensitivity index). [ Time Frame: 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 28 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female
  • premenopausal
  • obesity
  • PCOS.

Exclusion Criteria:

  • pregnancy
  • type 2 diabetes or impaired glucose tolerance
  • hypothyroidism
  • hyperprolactinaemia
  • Cushing's syndrome
  • nonclassical congenital adrenal hyperplasia
  • previous (within the last 6 months) use of oral contraceptives
  • glucocorticoids
  • antiandrogens
  • ovulation induction agents
  • antidiabetic and antiobesity drugs, or other hormonal drugs.

None of the subjects was affected by any neoplastic, metabolic, hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, and malabsorptive disorders),acute and chronic inflammations based on medical history, physical examination, and routine laboratory tests, including measurement of oral temperature, white blood cell count and urinalysis.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948402


Sponsors and Collaborators
Federico II University
Investigators
Principal Investigator: Annamaria Colao, MD PhD Department of Molecular and Clinical Endocrinology and Oncology Federico II University of Naples
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Annamaria Colao, Dept of Moll Clin Endocrinol Oncol, University Federico II of Naples
ClinicalTrials.gov Identifier: NCT00948402     History of Changes
Other Study ID Numbers: NeuroendoUnit-11
First Posted: July 29, 2009    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: October 2009

Keywords provided by Federico II University:
PED/PEA-15 protein
PCOS
IR
 metformin
OCP
Oral Contraceptive

Additional relevant MeSH terms:
Syndrome
Hypersensitivity
Insulin Resistance
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
 Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Metformin
Contraceptive Agents
Contraceptives, Oral
Hypoglycemic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Contraceptive Agents, Female